Description

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LEEPRA film-coated tablet are an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
LEEPRA is used on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation
•as an add-on to other antiepileptic medicines to treat:
•partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age
•myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
•primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy

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BEFORE YOU TAKE LEEPRA

Do not take LEEPRA:
•If you are allergic (hypersensitive) to Levetiracetam or any of the other ingredients of this medicine (listed in Section 6).

Warnings and Precautions
Talk to your doctor before taking LEEPRA
•If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.
•If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
•If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.
•A small number of people being treated with anti-epileptics such as LEEPRA have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Other medicines and LEEPRA
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

LEEPRA with food, drink and alcohol
You may take LEEPRA with or without food. As a safety precaution, do not take LEEPRA with alcohol.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or if you think you may be pregnant, please inform your doctor.
LEEPRA should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown.
LEEPRA has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.
Breast-feeding is not recommended during treatment.

Driving and using machines:
LEEPRA may impair your ability to drive or operate any tools or machinery, as LEEPRA may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

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HOW TO TAKE LEEPRA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
LEEPRA must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Take the number of tablets following your doctor’s instructions.
Monotherapy
Dose in adults and adolescents (from 16 years of age):
General dose: between 1000 mg and 3,000 mg each day.
When you will first start taking LEEPRA, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
•General dose: between 1,000 mg and 3,000 mg each day.

Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of LEEPRA according to the age, weight and dose.
An LEEPRA 100 mg/ml oral solution is a presentation more appropriate to infants and children under the age of 6 years.
General dose: between 20 mg per kg bodyweight and 60 mg per kg body weight each day.

Dose in infants (1 month to less than 6 months):
An LEEPRA 100 mg/ml oral solution is a presentation more appropriate to infants.

Method of administration:
Swallow LEEPRA tablets with a sufficient quantity of liquid (e.g. a glass of water).

Duration of treatment:
•LEEPRA is used as a chronic treatment. You should continue LEEPRA treatment for as long as your doctor has told you.
•Do not stop your treatment without your doctor’s advice as this could increase your seizures. Should your doctor decide to stop your LEEPRA treatment, he/she will instruct you about the gradual withdrawal of LEEPRA.

If you take more LEEPRA than you should:
The possible side effects of an overdose of LEEPRA are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take LEEPRA:
Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for a forgotten tablet.

If you stop taking LEEPRA:
If stopping treatment, as with other antiepileptic medicines, LEEPRA should be discontinued gradually to avoid an increase of seizures.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.
Very common:
•nasopharyngitis;
•somnolence (sleepiness), headache.
Common: may affect 1 to 10 users in 100
•anorexia (loss of appetite);
•depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
•convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary
trembling);
•vertigo (sensation of rotation);
•cough;
•abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
•rash;
•asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000
•decreased number of blood platelets, decreased number of white blood cells;
•weight decrease, weight increase;
•suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
•amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
•diplopia (double vision), vision blurred;
•liver function test abnormal;
•hair loss, eczema, pruritus;
•muscle weakness, myalgia (muscle pain);
•injury.

Rare: may affect 1 to 10 users in 10,000
•infection;
•decreased number of all blood cell types;
•suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
•uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesias (hyperactivity);
•pancreatitis;
•hepatic failure, hepatitis;
•skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

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HOW TO STORE LEEPRA

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton box, blister & bottle label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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FURTHER INFORMATION

What LEEPRA contains
The active substance is called Levetiracetam
Each film-coated tablet contains 500 mg

Other available strengths are 250 mg/ 750 mg/ 1000 mg Levetiracetam.

The other ingredients are:
Tablet core: Maize starch, silica colloidal anhydrous (E551), povidone (K-30) (E1201), talc (E553b), magnesium stearate (E470b).
Film-coating:
500 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171),
macrogol 4000, iron oxide yellow (E172).

What LEEPRA looks like and contents of the pack
Film-coated tablet.
500 mg film-coated tablets
Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating on one side and plain on the other side. The tablet can be divided into equal halves.

LEEPRA film-coated tablets are packaged in PVC/PE/PVdC –
Aluminium foil blister pack or HDPE bottle with polypropylene cap pack.

Pack size:
Blister pack: 20, 30, 50, 60, 100, 200 and 500 film-coated tablets
Bottle pack: 30, 100, 200 and 500 film-coated tablets
Not all pack sizes may be marketed.